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EC number: 695-619-1 | CAS number: 623-72-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022-03-02 ~ 2022-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ethyl 3-hydroxypropanoate
- Cas Number:
- 623-72-3
- Molecular formula:
- C5H10O3
- IUPAC Name:
- ethyl 3-hydroxypropanoate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Without and with S9 mix : (TA98, TA100, TA1535, TA1537, WP2uvrA )
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 1. Concentration range-finding test
According to the guidelines, 5000 μg/plate was the maximum concentration and the following concentrations were set to common ratio of about √10.
Test strain : TA100, TA1535, TA98, TA1537, WP2uvr A
With and without S9 mix concentration (μg/plate) : 50, 150, 500, 1500, 5000
2. In the concentration range-finding test, microbial toxicity was not observed at the any concentration in the presence and absence of S9 mix. Precipitation was not observed on the
agar plates at the any concentration in the presence and absence of S9 mix. Based on the above result, main test were conducted at the following concentrations.
Test strain : TA100, TA1535, TA98, TA1537, WP2uvr A
With and without S9 mix concentration (μg/plate) : 313, 625, 1250, 2500, 5000 - Vehicle / solvent:
- 1. Negative control substance
In the preliminary test for the selection of the negative control, the test substance was dissolved at 50 mg/mL in DMSO. No heat, discoloration or foaming was observed in the preparation using DMSO. Based on this result, DMSO was selected as the vehicle for the test substance and used as the negative control substance in this study.
2. Positive control substance
These chemicals are widely used in reverse mutation assays using bacteria and are recommended in the OECD guidelines for the testing of chemicals, section 4, test No. 471.
Furylfuramide (AF-2), Sodium azide(NaN3), 2aminoanthracene (2AA), 9-Aminoacridine (9AA), Benzo(a)pyrene
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO.
- True negative controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- benzo(a)pyrene
- furylfuramide
- other:
- Details on test system and experimental conditions:
- 1. Storage of the test strains
- Composition
Bacterial suspension (0.8 mL) of each test strain, which was cultured with shaking for 10 hours
at 37°C in the liquid growth medium, was mixed with 0.07 mL of DMSO (Wako pure chemical industries, Ltd.,).
- Storage : Divided portions (0.5 mL) were frozen
- Storage conditions : below −70 ℃
- Storage date : 2021-06-30 (Concentration range finding test), 2022-03-08 (main test)
- Expiration date :2022-06-29 (Concentration range finding test) 2023-03-07 (main test)
2. Pre-culture
- Pre-culture temperature: 37 ℃
- Pre-culture time: 10 hours
- Pre-culture method: Reciprocal shaking (Shaking frequency: 120 times/minute)
- Pre-culture vessel: 50 mL Erlenmeyer flask.
- Media: Nutrient broth 15 mL
- Strain and volume of inoculate: A frozen stock suspension of the test strain will be thawed
and 0.01 mL will be inoculated. - Rationale for test conditions:
- Reason for selection of the test strains
These strains are widely used in reverse mutation assays using bacteria and are recommended in the OECD guidelines for the testing of chemicals, section 4, test No. 471. - Evaluation criteria:
- The test strains were chosen because they are very sensitive to mutagens and widely used in mutagenicity studies with bacteria.
This study was conducted in compliance with the methods described in OECD Guidelines for the testing of chemicals, Section 4, TG. No. 471 'Bacterial Reverse Mutation Test' (Adopted : 1997-07-21, Corrected : 2020-06-26).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- 1. Main test
Microbial toxicity was not observed at any concentration in the presence and absence of S9 mix. Precipitation was not observed on the agar plates at the any concentration in the presence and absence of S9 mix.
The number of revertant colonies in the test substance-treated groups was less than twice that in the corresponding negative control in any test strain regardless of the presence or absence of S9 mix.
2. Sterility test
Microbial contamination was not observed in the highest concentration of the test substance solution and S9 mix in the sterility test group in concentration range finding test and main test.
Applicant's summary and conclusion
- Conclusions:
- Therefore, it was concluded that Ethyl 3-hydroxypropanoate was not mutagenic (negative) under the conditions employed in the present study.
- Executive summary:
Based on the results of the concentration range-finding test, main test, the number of revertant colonies in the test substance-treated groups was less than twice that in the
corresponding negative control in any test strain regardless of the presence or absence of S9 mix. The reproducibility of the test results were confirmed with the concentration range-finding test and main tests.
The numbers of revertant colonies in the negative control and positive control groups in the present study were within the acceptable ranges stipulated at the testing facility (Appendix 1).
The positive controls used in the assays with the presence or absence of S9 mix showed positive responses in every test strains, as evidenced by the number of revertant colonies
being greater than 2-fold of the respective negative control value. In each test, there were 4 or more concentrations did not show microbial toxicity and at least 5 concentrations in all
strains were analyable both in the presence and absence of S9 mix. Consequently, the validity of the present study was confirmed.
Therefore, it was concluded that Ethyl 3-hydroxypropanoate was not mutagenic (negative) under the conditions employed in the present study.
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